The following criteria is provided for health care professionals.
Entry Criteria:
Disease Characteristics:
- Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.
- Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy.
- Progressive disease is defined by a 25% increase from the lowest response value in specified tests.
- Measurable disease as defined by at least one of the following:
- Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)
- Urine M-protein ≥ 200mg/24hours
- Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio
Prior/Concurrent Therapy:
- No anti-myeloma treatments within 28 days before the start of study treatment.
- Must have recovered from side effects of prior treatments.
Patient Characteristics:
Performance Status
Bone Marrow Reserve
- Absolute neutrophil count (AGC/ANC) ≥ 1000/uL
- Platelets ≥ 30,000/uL
- Hemoglobin ≥ 8g/dL
- Absolute lymphocytes ≥ 800/uL
- Leukocytes ≥ 3,000/uL
Renal Function
- Glomerular Filtration Rate (GFR) > 45mL/min/1.73m^2
Hepatic Function
- Total bilirubin ≤ 2.0 X ULN
- AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist)
- No positive Hep C serology or active Hep B infection
Cardiovascular
- No congestive heart failure < 6 months
- No unstable angina pectoris < 6 months
- No myocardial infarction < 6 months
- No history of ventricular arrhythmias
- No history of supraventricular arrhythmias
- No NYHA Class > II CHF
- No marked baseline prolongation of QT/QTc interval
Pulmonary
- Normal clinical assessment of pulmonary function
Other
- Negative serum pregnancy test if female and of childbearing potential
- Women who are not pregnant or nursing
- Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
- No known autoimmune disease other than corrected hypothyroidism
- No known prior organ allograft or allogeneic transplantation
- Not HIV positive
- No history or evidence of uncontrollable CNS disease
- No psychiatric illness/social situation
- No other illness that in the opinion of the investigator would exclude the subject from participating in the study
- Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
- No active systemic infection requiring parenteral antibiotic therapy
- No ongoing chronic systemic steroid therapy or regular inhaled cortocosteroid use